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Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™. (PERSIST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405872
First Posted: July 29, 2011
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

Condition Intervention
Multiple Sclerosis Other: AVONEX PEN

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Persistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Tolerability of Avonex PEN as measured by Injection Site Pain [ Time Frame: Months 3, 6, and 12 ]
  • Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire [ Time Frame: Months 3, 6, and 12 ]
  • Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale [ Time Frame: Month 3 ]
  • Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Ease of Use Grading Scale [ Time Frame: Months 3, 6, and 12 ]
  • Patient reported adherence as measured by number of doses missed [ Time Frame: Over the first 6 months and during Months 6 & 12 ]
  • Physician reported persistence as measured by number of patients still on therapy [ Time Frame: Month 6 ]
  • Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire [ Time Frame: Months 3, 6 and 12 ]
  • Patient reported fear of injection using the Fear of Injection Scale [ Time Frame: Months 3, 6 and 12 ]
  • Percent of patients switching from caregiver to self-injection [ Time Frame: Months 3, 6, and 12 ]
  • Tolerability of Avonex PEN as measured by Injection Site Reaction [ Time Frame: Months 3, 6 and 12 ]
  • Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Patient Assessment of Injection Procedure [ Time Frame: Months 3, 6 and 12 ]

Enrollment: 270
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: AVONEX PEN
    Participants receive Avonex PEN commercially prescribed according to the local prescribing information.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Sclerosis patients who have made the decision, along with their health care provider, to begin therapy with Avonex PEN.
Criteria

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent
  • Must satisfy the locally approved therapeutic indications for the Avonex PEN
  • Decision to treat with Avonex PEN must precede enrollment
  • Must have no more than two (2) injections with the Avonex PEN prior to enrollment

Exclusion Criteria:

  • Inability to comply with study requirements
  • Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405872


  Show 64 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01405872     History of Changes
Other Study ID Numbers: 108MS402
First Submitted: July 28, 2011
First Posted: July 29, 2011
Last Update Posted: September 9, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents